510(k) Report

Devices descending from K052472

158 later devices reach Depuy Global Shoulder Crosslink Glenoid through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+6K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+6K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+6K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+6K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+6K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+6K243509Archer PSI System3D-Side20250—
+6K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+6K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+6K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+6K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+6K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+6K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+6K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+6K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+6K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+6K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+6K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+6K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+6K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+6K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+6K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+6K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+6K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+7K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+7K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+7K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+7K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+7K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+7K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+7K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+7K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+7K210153NextAR RSA PlatformMedacta International S.A.202151
+7K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+7K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+8K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+8K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+8K252847NextAR Hip PlatformMedacta International S.A.20260—
+8K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+8K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+8K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+8K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+8K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+8K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+8K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+8K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+8K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+8K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+8K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+9K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+9K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+10K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—